Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Boston University

Status: Invitation-only

Conditions: Tooth Loss

Treatments: Procedure: CAD-CAM designed and preprinted Ti-Mesh frame; Procedure: Conventional chairside fabrication of Ti-Mesh frame

Study type: Interventional

Funder types: Other

Identifiers

NCT06077513

H-43856

AP 37 (Other Identifier)

Details and patient eligibility

About

This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.

The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.

A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:

1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partially edentulous
• Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement

Exclusion criteria

• Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
• Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
• Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
• Subjects under the direct supervision of the PI
• Smoking more than 10 cigarettes per day
• Uncontrolled diabetes or other metabolic disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CAD-CAM Ti-Mesh frame

Experimental group

Description:

Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.

Treatment:

Procedure: CAD-CAM designed and preprinted Ti-Mesh frame

Conventional Ti-Mesh frame

Active Comparator group

Description:

Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery.

Treatment:

Procedure: Conventional chairside fabrication of Ti-Mesh frame